Febrile Urinary Tract Infection Randomized Short Treatment Trial - Full Text View

Sponsor:	Leiden University Medical Center
Collaborators:	Bronovo Hospital Medical Center Haaglanden Spaarne Hospital Rijnland Hospital Diaconessenhuis Leiden Groene Hart Hospital
Information provided by:	Leiden University Medical Center
ClinicalTrials.gov Identifier:	NCT00809913

Purpose

The purpose of this study is to determine whether a 7-day duration of antibiotic treatment of febrile urinary tract infection (FUTI) is non inferior to 14-day standard duration of treatment in unselected population presenting at primary care or emergency department.

Condition	Intervention	Phase
Urinary Tract Infection	Drug: short treatment (ciprofloxacin)	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment
Official Title:	Relevance of Biomarkers and Clinical Predictors of Outcome in Unselected Population With Febrile Urinary Tract Infection at Primary Care and Emergency Department in a Prospective, Randomized Cohort Trial Comparing Short (7 Days) Antibiotic Treatment With Conventional Treatment (14 Days)

Resource links provided by NLM:

MedlinePlus related topics: Antibiotics Fever Urinary Tract Infections

Drug Information available for: Ciprofloxacin Ciprofloxacin hydrochloride Ciprofloxacin lactate

U.S. FDA Resources

Further study details as provided by Leiden University Medical Center:

Primary Outcome Measures:

Clinical cure rate through the 10- to 18-day posttherapy visit. Clinical cure is defined as the resolution of fever and signs and symptoms of UTI. [ Time Frame: 10-18 day posttherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Microbiological cure rate 10- to 18-day posttherapy [ Time Frame: 10-18 day posttherapy ] [ Designated as safety issue: No ]
All cause mortality [ Time Frame: 30 and 90 days ] [ Designated as safety issue: No ]
Clinical cure rate 70- to 84- day posttherapy [ Time Frame: 70-84 days posttherapy ] [ Designated as safety issue: No ]
Relapse rate of any urinary tract infection [ Time Frame: 90 days ] [ Designated as safety issue: No ]
Adverse events [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
Rate of pelvic floor dysfunction as assessed by standardized questionaire [ Time Frame: 10-18 days posttherapy ] [ Designated as safety issue: No ]
Occurence of Clostridium Difficile associated diarrhea [ Time Frame: 90 days ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	December 2008
Estimated Study Completion Date:	December 2011
Estimated Primary Completion Date:	September 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Short treatment 7 days of standard antibiotic treatment (preferably ciprofloxacin) followed by 7 days of placebo	Drug: short treatment (ciprofloxacin) 7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days
Active Comparator: Standard treatment 14 days of standard antibiotic treatment (initial b-lactam or fluoroquinolone followed by ciprofloxacin through the 8th till 14th day)	Drug: short treatment (ciprofloxacin) 7 days of antibiotic treatment for febrile urinary tract infection / acute pyelonephritis compared to standard treatment of 14 days

Detailed Description:

In the last decades hospitalization rates of patients with acute pyelonephritis (AP) or FUTI has decreased from almost 100% to 10-30%. The outpatient management of patients with FUTI has become popular as well as oral antimicrobial treatment regiments and shortening of treatment duration. However, as such approaches are only discovered in otherwise young health non-pregnant women, the best management of FUTI in the elderly, men and patients with co-morbidity remains elusive. Bases on personal perception of the attending physician antibiotic treatment, duration varies approximately between 7-14 days. Facing the aging of the general population, it is urgent to better define the optimal treatment for AP or FUTI in an unselected population and to identify those at risk for treatment failure or poor outcome to guide and optimize individual patient management and to prevent on the one hand unnecessary long treatment duration and hospital admission and on the other hand unsafe short duration or unsafe outpatient management.

In this study the efficacy and safety of a 7-day antimicrobial regimen compared to a 14-day antimicrobial regimen will be evaluated in an unselected population presenting with FUTI at primary care or emergency department. In addition a clinical and/or biomarker based scoring system of disease severity will be derived to predict those at risk for treatment failure or poor outcome.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Competent patient aged 18 years or above
One or more symptom(s) suggestive of urinary tract infection (dysuria, frequency or urgency*; perineal or suprapubic pain; costo-vertebral tenderness or flank pain)
Fever (ear or rectal temp of 38.2 oC or higher, or axillary temp of 38 oC or higher), or history of feeling feverish with shivering or rigors in the past 24 hours
Positive urine nitrate test and/or leucocyturia as depicted by positive leukocyte esterase test or microscopy

Exclusion Criteria:

Known allergy to fluoroquinolones
Female patients who are pregnant or lactating
Patients with known polycystic kidney disease
Patients on permanent renal replacement therapy (hemodialysis or peritoneal dialysis)
Patients with history of kidney transplantation
Residence outside country of enrolment
Inability to speak or read Dutch
Isolated causal uropathogen resistant to ciprofloxacin
Renal abscess
Chronic bacterial prostatitis
Suspicion or evidence of any metastatic infectious foci

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00809913

Contacts

Contact: Cees van Nieuwkoop, MD	+31-71-5262613	c.van_nieuwkoop@lumc.nl
Contact: Jaap T. van Dissel, MD, PhD	+31-71-5262613	j.t.van_dissel@lumc.nl

Locations

Netherlands
Bronovo Hospital	Recruiting
Den Haag, Netherlands, 2509 JH
Contact: Jan van't Wout, MD, PhD +31-70-3124141 jvtwout@bronovo.nl
Sub-Investigator: Jan van't Wout, MD, PhD
Medical Center Haaglanden	Recruiting
Den Haag, Netherlands, 2501 CK
Contact: Eliane M.S. Leyten, MD, PhD +70-31-3302000 e.leyten@mchaaglanden.nl
Sub-Investigator: Eliane M.S. Leyten, MD, PhD
Groene Hart Hospital	Recruiting
Gouda, Netherlands, 2800 BB
Contact: Ted Koster, MD, PhD +31-182-505050 ted.koster@ghz.nl
Sub-Investigator: Ted Koster, MD, PhD
Spaarne Hospital	Not yet recruiting
Hoofddorp, Netherlands, 2134 TM
Contact: G. Hanke Wattel - Louis, MD +31-23-8907171 hwattel@spaarneziekenhuis.nl
Sub-Investigator: G. Hanke Wattel - Louis, MD
Diaconessenhuis Leiden	Recruiting
Leiden, Netherlands, 2334 CK
Contact: Hans C. Ablij, MD +31-71-5178178 hcablij@diaconessenhuis.nl
Sub-Investigator: Hans C. Ablij, MD
Leiden University Medical Center	Recruiting
Leiden, Netherlands, 2300 RC
Contact: Cees van Nieuwkoop, MD +31-71-5262613 c.van_nieuwkoop@lumc.nl
Contact: Jaap T. van Dissel, MD,PhD +31-71-5262613 j.t.van_dissel@lumc.nl
Principal Investigator: Cees van Nieuwkoop, MD
Rijnland Hospital	Recruiting
Leiderdorp, Netherlands, 2350 CC
Contact: Natahalie M. Delfos, MD +31-71-5828282 n.delfos@rijnland.nl
Sub-Investigator: Nathalie M. Delfos, MD

Sponsors and Collaborators

Leiden University Medical Center

Bronovo Hospital

Medical Center Haaglanden

Spaarne Hospital

Rijnland Hospital

Diaconessenhuis Leiden

Groene Hart Hospital

Investigators

Study Chair:	Jaap T. van Dissel, MD, PhD	Leiden University Medical Center
Principal Investigator:	Cees van Nieuwkoop, MD	Leiden University Medical Center

More Information

Publications:

van Nieuwkoop C, van't Wout JW, Assendelft WJ, Elzevier HW, Leyten EM, Koster T, Wattel-Louis GH, Delfos NM, Ablij HC, Kuijper EJ, Pander J, Blom JW, Spelt IC, van Dissel JT. Treatment duration of febrile urinary tract infection (FUTIRST trial): a randomized placebo-controlled multicenter trial comparing short (7 days) antibiotic treatment with conventional treatment (14 days). BMC Infect Dis. 2009 Aug 19;9:131.

Responsible Party:	C. van Nieuwkoop, MD, Leiden University Medical Center, Dept. of Infectious Diseases, C5P
ClinicalTrials.gov Identifier:	NCT00809913 History of Changes
Other Study ID Numbers:	NL22172.058.08
Study First Received:	December 16, 2008
Last Updated:	June 30, 2011
Health Authority:	Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Leiden University Medical Center:

Urinary Tract Infection
Fever
Acute Pyelonephritis
Treatment duration
Febrile Urinary Tract Infection Treatment Duration

Additional relevant MeSH terms:

Urinary Tract Infections
Infection
Urologic Diseases
Anti-Bacterial Agents
Ciprofloxacin
Anti-Infective Agents

Therapeutic Uses
Pharmacologic Actions
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012